NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the prep
Summary
The FDA issued a Class II for NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder by Fresenius Medical Care Holdings, Inc.. Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions.
Details
Source
Device Recall
External ID
Z-2087-2021
Action Date
2021-07-28
Status
Terminated
Category
device
Product Description
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
Lot/Code Info: Lot Number: 21ATBC004 UDI: (01)00840861101955
Quantity Affected: 120 Bags
Reason for Recall
Exposed to freezing temperatures due to refrigerated truck malfunctions
Distribution
US Distribution to: TX only
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-28
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Medical Care Holdings, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Medical Care Holdings, Inc. have FDA actions?
Fresenius Medical Care Holdings, Inc. has 69 FDA actions in our database, including 69 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2087-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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